Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 45
Updated:4/2/2016
Start Date:February 2005
End Date:July 2007
Contact:Charlotte A Clock, M.D.
Email:cclock@uci.edu
Phone:714-456-5967

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Transvaginal ultrasound of the cervix has become a common tool to evaluate patients who are
at risk for preterm delivery. A shortened cervical length has been associated with an
increased risk of preterm delivery. Dynamic cervical change is visible shortening(>6mm) of
the cervix seen during the ultrasound examination. Prior studies have shown that the
presence of dynamic change in patients with a shortened cervical length(<3cm) is not
independently predictive of preterm delivery. However, a subset of patients with normal
initial cervical length(>3cm) and dynamic change did demonstrate an increased rate of
preterm delivery. Because this was a small sub-group, the present study was designed to
obtain a larger sample size for further evaluation. The second focus of this study involves
patients with a dilated cervix and whether cervical length adds predictive value to
gestational age at delivery.

Patients presenting to with symptomatic preterm labor(vaginal pressure or uterine
contractions), who consent to the study, will undergo the standard evaluation for preterm
labor(described in detail below.) The only additional evaluation is a prolonged transvaginal
ultrasound of approximately 10 minutes to evaluate for the presence of dynamic change during
a contraction.

Null hypothesis:

Symptomatic preterm labor patients, with normal initial cervical length(>3cm), who exhibit
dynamic cervical change deliver at a gestational age equal to those without dynamic change.

Alternative hypothesis:

Symptomatic preterm labor patients, with normal initial cervical length(>3cm), who exhibit
dynamic cervical change deliver at an earlier gestational age than those without dynamic
change.


Inclusion Criteria:

- Pregnant women between the ages of 18 and 45 years.

- Intrauterine pregnancy with gestational age between 22 0/7 and 34 6/7 weeks
gestation.

- Presenting with symptomatic preterm labor (e.g. Regular uterine contractions, uterine
cramping, or pelvic pressure).

Exclusion Criteria:

- Cervical cerclage

- Ruptured membranes noted on initial speculum examination

- Cervical os dilation >4 cm noted on initial digital examination

- Known HIV-positive or active HSV(to minimize the risk of perinatal exposure)

- Presence of multiple genital warts

- Patients under extreme duress from their uterine contractions
We found this trial at
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Laguna Hills, California 92653
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Long Beach, California 90801
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101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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